The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
187
Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
Westmead Hospital
Westmead, New South Wales, Australia
Medical University of Vienna
Vienna, Austria
ULB Erasme Hospital
Brussels, Belgium
Stent Removability
Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.
Time frame: At stent removal
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St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, Canada
MUHC - McGill University
Montreal, Quebec, Canada
Clinica Alemana de Santiago
Santiago, Chile
Hopital Edouard Herriot
Lyon, France
Evangelischen Krankenhaus
Düsseldorf, Germany
Asian Institute of Gastroenterology
Hyderabad, India
...and 3 more locations